AstraZeneca seeks US authorization for drug to prevent COVID-19

October 5 (Reuters) – AstraZeneca (AZN.L) has asked US regulators for emergency use authorization for its new treatment to prevent COVID-19 in people who react poorly to vaccines due to a system weakened immune system.

In a statement on Tuesday, the Anglo-Swedish drugmaker said it had included in its filing with the Food and Drug Administration data from an advanced trial that showed the drug to reduce by 77% the risk of developing symptoms of COVID-19.

Antibody therapy called AZD7442 could protect people who do not have a strong enough immune response to COVID-19 vaccines or supplement a vaccination course for those, like military personnel, who need to further boost their protection, said AstraZeneca.

While vaccines rely on an intact immune system to develop targeted antibodies and infection-fighting cells, AZD7442 contains lab-made antibodies designed to persist in the body for months to contain the virus if it occurs. infection.

US clearance for AZD7442 – based on two antibodies discovered by Vanderbilt University Medical Center in the US – could be a major victory for AstraZeneca, whose widely used COVID-19 vaccine has yet to be approved by authorities American.

Discussions regarding supply agreements for AZD7442 are underway with the United States and other governments, AstraZeneca said.

COVID-19 therapies based on the same class of monoclonal antibodies are being developed by rivals Regeneron (REGN.O), Eli Lilly (LLY.N) and GlaxoSmithKline (GSK.L) with its partner Vir (VIR.O), competing for a role in the treatment and prevention of COVID-19. But Astra’s case has consolidated its lead in prevention.

This contrasts with delays in Astra’s search for approval of its COVID-19 vaccine Vaxzevria in the United States, where the vast majority of those who wish to be vaccinated have received vaccines from the Pfizer-BioNTech alliance ( PFE.N) (22UAy.DE), Moderna (MRNA.O) or Johnson & Johnson.

Astra said in July that it expected to seek US approval for the vaccine in the second half of this year. Read more

The results of the AZD7442 therapy trial, first published in August, were collected three months after the injection, but the company hopes it can present the vaccine as a one-year shield as investigators from the ‘trial will follow participants for up to 15 months. Read more

Report by Sachin Ravikumar in Bengaluru and Ludwig Burger in Frankfurt; Editing by Sriraj Kalluvila and Barbara Lewis

Our Standards: The Thomson Reuters Trust Principles.